A Randomized Controlled Trial of a Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of a mindfulness program as a treatment for hip or knee osteoarthritis on the WOMAC pain score.
研究概览
简要总结
Symptomatic osteoarthritis (OA) is the most common joint disease and the leading cause of disability in industrialized countries. Therapeutic approaches to prevent the development and progression of osteoarthritis are disappointing and very limited. New therapeutic alternatives seem essential to better manage his daily life. Non-drug approaches, including psycho-corporal approaches are increasingly used in the management of chronic pain.
Mindfulness is a technique of attention training, which is to focus one's attention on the present moment and to examine the sensations that come to mind, how they appear, how they last time, and how they disappear.
Regarding rheumatological pathologies, a Mindfulness Program (MBSR) has shown its effectiveness in chronic pain; and in particular in osteo-articular localization, such as chronic low back pain. A recent study found a correlation between a pre-disposition to mindfulness and less pain and / or better quality of life in patients with knee osteoarthritis. However, to the knowledge of investigator, no study has evaluated the effectiveness of an intervention based on a mindfulness training program as a therapeutic alternative in osteoarthritis of the knee or hip.
The goal of investigator is to evaluate, using a randomized, controlled study, the effect of a mindfulness program (according to the MBSR protocol) on pain, function, psychological state and quality of life patients with knee or hip osteoarthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the knee or hip (Kellgren and Lawrence X-ray stage ≥ 2)
- •Mean pain VAS on at least one reference joint (knee or hip)> 40 mm during the last week
- •Stable treatment with analgesics for at least a week
排除标准
- •Corticosteroids (oral or injectable) in the month prior to inclusion
- •Intra-articular injection of hyaluronic acid in the last 3 months prior to inclusion
- •Inflammatory rheumatic disease (rheumatoid arthritis, spondyloarthritis, CCPD)
- •Current depressive episode
- •Psychotic disorders
- •Usual practice of a relaxation method (mindfulness, yoga, sophrology ...)
- •Major protected by law (guardianship, curatorship or under the safeguard of justice)
- •Subject in a period of exclusion relative to another protocol or for which the annual amount maximum compensation of € 4500 has been reached.
- •Subject participating in another research protocol
- •Subject not affiliated to a social security
- •Pregnant woman, parturient or nursing, patient unable to give her major consent protected, vulnerable persons (Articles L.1121-6, L.1121-7, L.1211-8, L.1211-9)
- •Subject deprived of liberty by judicial or administrative decision
结局指标
主要结局
Evaluate the efficacy of a mindfulness program as a treatment for hip or knee osteoarthritis on the WOMAC pain score.
时间窗: 6 months
Improvement in WOMAC pain before and after the program in the MBSR group compared to control group. The WOMAC is a validated index in the assessment of lower extremity osteoarthritis, by the system of rating the answers to questions by a visual analogue scale from 0 to 100 mm. It is possible to calculate the scores in each domain (pain, stiffness and function) or for the whole WOMAC. This is a self-administered questionnaire completed by the patient.
次要结局
- Changes in OARSI-OMERACT response criteria between initiation visit and 6 months(6 months)
- Changes in SF-36 score between initiation visit and 6 months(6 months)
- Changes in HAD score between initiation and 6 months(6 months)
- Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 3 months(3 months)
- Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 6 months(6 months)
- Changes in OARSI-OMERACT response criteria between initiation visit and 3 months(3 months)
- Changes in HAD score between initiation and 3 months(3 months)
- Changes in pain scores (VAS/100) between initiation visit and 3 months(3 months)
- Changes in pain scores (VAS/100) between initiation visit and 6 months(6 months)
- Changes in SF-36 score between initiation visit and 3 months(3 months)